Vascular device with valve for approximating vessel wall

ABSTRACT

A vascular device comprising a plurality of vessel engaging members and a valve. The device is movable from a collapsed insertion position having a first diameter to a second expanded position having a second diameter larger than the first diameter. The plurality of vessel engaging members extend outwardly from the device for securely engaging the internal wall of a vessel upon expansion of the device to the second expanded position, wherein the vessel engaging members pull the internal wall of the vessel radially inwardly upon movement of the device from the second expanded position toward a first expanded position having a third diameter greater than the first diameter and less than the second diameter. In the first expanded position the valve is movable between an open position to allow blood flow therethrough to a closed position to prevent blood flow.

This application is a continuation of patent application Ser. No.12/880,499 filed on Sep. 13, 2010, which is a continuation of patentapplication Ser. No. 10/706,685 filed on Nov. 12, 2003, now U.S Pat. No.7,833,262, which is a divisional of application Ser. No. 10/011,345filed on Dec. 5, 2001 now U.S Pat. No. 6,676,698, which claims benefitof provisional application No. 60/317,801 filed on Sep. 7, 2001 and is acontinuation-in-part of U.S patent application Ser. No. 09/877,639 filedJun. 8, 2001, now U.S Pat. No. 6,695,878, and a continuation-in-part ofU.S patent application Ser. No. 09/877,480 filed Jun. 8, 2001, now U.SPat. No. 6,527,800, both of which claim priority from U.S Provisionalpatent application No. 60/214,120 filed on Jun. 26, 2000. The entirecontents of each of these applications are incorporated herein byreference.

BACKGROUND

Technical Field

This application relates to a vascular device and more particularly to avascular device for approximating the vessel wall and placing a valvefor treating venous valve insufficiency.

Background of Related Art

Veins in the body transport blood to the heart and arteries carry bloodaway from the heart. The veins have one-way valve structures in the formof leaflets disposed annularly along the inside wall of the vein whichopen to permit blood flow toward the heart and close to prevent backflow. That is, when blood flows through the vein, the pressure forcesthe valve leaflets apart as they flex in the direction of blood flow andmove towards the inside wall of the vessel, creating an openingtherebetween for blood flow. The leaflets, however, do not normally bendin the opposite direction and therefore return to a closed position toprevent blood flow in the opposite, i.e. retrograde, direction after thepressure is relieved. The leaflet structures, when functioning properly,extend radially inwardly toward one another such that the tips contacteach other to block backflow of blood.

In the condition of venous valve insufficiency, the valve leaflets donot function properly as they thicken and lose flexibility, resulting intheir inability to extend sufficiently radially inwardly to enable theirtips to come into sufficient contact with each other to preventretrograde blood flow. The retrograde blood flow causes the buildup ofhydrostatic pressure on the residual valves and the weight of the blooddilates the wall of the vessel. Such retrograde blood flow, commonlyreferred to as reflux, leads to swelling and varicose veins, causinggreat discomfort and pain to the patient. Such retrograde blood flow, ifleft untreated can also cause venous stasis ulcers of the skin andsubcutaneous tissue. There are generally two types of venous valveinsufficiency: primary and secondary. Primary venous valve insufficiencyis typically a condition from birth, where the vein is simply too largein relation to the leaflets so that the leaflets cannot come intoadequate contact to prevent backflow. More common is secondary venousvalve insufficiency which is caused by clots which gel and scar, therebychanging the configuration of the leaflets, i.e. thickening the leafletscreating a “stub-like” configuration. Venous valve insufficiency canoccur in the superficial venous system, such as the saphenous veins inthe leg, or in the deep venous system, such as the femoral and poplitealveins extending along the back of the knee to the groin.

A common method of treatment of venous valve insufficiency is placementof an elastic stocking around the patient's leg to apply externalpressure to the vein, forcing the walls radially inwardly to force theleaflets into apposition. Although sometimes successful, the tightstocking is quite uncomfortable, especially in warm weather, as thestocking must be constantly worn to keep the leaflets in apposition. Theelastic stocking also affects the patient's physical appearance, therebypotentially having an adverse psychological affect. This physical and/orpsychological discomfort sometimes results in the patient remove thestocking, thereby preventing adequate treatment.

Another method of treatment has been developed to avoid the discomfortof the stocking. This method involves major surgery requiring theimplantation of a cuff internally of the body, directly around the vein.This surgery requires a large incision, resulting in a long patientrecovery time, scarring and carries the risks, e.g. anesthesia, inherentwith surgery.

Another invasive method of surgery involves selective repairing of thevalve leaflets, referred to as valvuloplasty. In one method, sutures areutilized to bring the free edges of the valve cusp into contact. Thisprocedure is complicated and has the same disadvantages of the majorsurgery described above.

Co-pending, commonly assigned U.S. patent application Ser. Nos.09/877,639 and 09/877,480, incorporated herein by reference, disclose anadvantageous method and device to minimally invasively treat venousvalve insufficiency without requiring an outer stocking or internalcuff. Such device avoids the physical and psychological discomfort of anexternal stocking as well as avoids the risk, complexity and expense ofsurgically implanted cuffs. The device is advantageously insertedminimally invasively, i.e. intravascularly, and functions to effectivelybring the valve leaflets into apposition. This device first expandsagainst the vessel wall to grasp the wall, and then contracts to bringthe vessel wall radially inwardly so the leaflets can be pulled closertogether to a functional position. The present application utilizes thedevice of these prior applications for bringing the vessel wall radiallyinwardly to correct the dilation of the wall, but rather than rely onthe patient's existing valve leaflets which may be scarred ornon-functional, contains a replacement valve as a substitute for thepatient's leaflets. Thus, advantageously, venous valve insufficiency canbe treated minimally invasively by bringing the vessel wall inwardly andreplacing the patient's valve.

SUMMARY

The present invention provides a vascular device comprising a pluralityof vessel engaging members and a valve. The device is movable from acollapsed insertion position having a first diameter to a secondexpanded position having a second diameter larger than the firstdiameter. The plurality of vessel engaging members extend outwardly fromthe device for securely engaging the internal wall of a vessel uponexpansion of the device to the second expanded position, wherein thevessel engaging members pull the internal wall of the vessel radiallyinwardly upon movement of the device from the second expanded positiontoward a first expanded position having a third diameter. This thirddiameter is greater than the first diameter and less than the seconddiameter. In the first expanded position the valve is movable between anopen position to allow blood flow therethrough to a closed position toprevent blood flow.

The device is preferably composed of shape memory material andpreferably the first expanded position substantially corresponds to thememorized position of the device. The device is expanded to the secondexpanded position by an expandable device, such as a balloon, positionedwithin the device.

In one embodiment, the device is initially movable from the collapsedposition to the first expanded position in response to exposure to bodytemperature, and is subsequently moved from the first expanded positionto the second expanded position by an expandable member. In anotherembodiment, the device is movable from the collapsed position to thesecond expanded position by the substantial simultaneous exposure tobody temperature and expansion by an expandable member.

The present invention also provides a vascular system comprising aballoon catheter having an elongated shaft and an expandable balloon, avascular device mounted over the expandable balloon and having a firstposition and a second expanded position, and a valve connected to thevascular device and movable between a closed position to prevent bloodflow and an open position to allow blood flow therethrough. The vasculardevice is expandable to the expanded position to engage the vessel wallsand returnable substantially to the first position to bring the wallsradially inwardly.

The vascular device in one embodiment comprises a shape memory materialand can be expandable first to a memorized condition in response toexposure to body temperature and subsequently expanded to the expandedposition by inflation of the balloon. Alternatively, the vascular devicecan be expandable to the expanded position as the device issubstantially simultaneously exposed to body temperature and the balloonis inflated. The device in another embodiment can be composed ofstainless steel and is expandable by the balloon below its elastic limitto enable return of the device to the first position.

In the foregoing devices and system, the vascular device can bereleasably connected to the balloon. The valve can be attached to adistal end of the vascular device to extend downstream of the devicewhen positioned within a patient. Alternatively, the valve can beattached to a proximal end of the vascular device to extend within acentral portion of the device when positioned within a patient. Thevalve is preferably substantially conical in shape. The valve canalternatively have a duckbill valve configuration. In one embodiment, alongitudinal axis of the valve is offset from a longitudinal axis of thevascular device. The valve may include a plurality of blood drainageopenings extending through a side wall. A reinforcement ring can beprovided adjacent the distal opening.

The present invention also provides a method for treating venous valveinsufficiency comprising:

inserting a delivery device and a vascular device having a replacementvalve into a target vessel adjacent the region of the removed portion ofleaflets;

deploying the vascular device to an enlarged diameter to securely engagethe internal wall of the vessel; and

reducing the diameter of the vascular device to move the vessel wallradially inwardly to reduce dilation of the vessel and implant thereplacement valve.

The method can further include the step of removing at least a portionof vein valve leaflets of a patient before inserting the vasculardevice.

In one embodiment, the method further comprises the step of deployingthe vascular device to a first expanded diameter prior to deploying thedevice to the enlarged diameter, the first expanded diameter being lessthan the enlarged diameter, and the step of reducing the diameter of thevascular device returns the device to a diameter substantially equal tothe first expanded diameter. In this embodiment, the step of deployingthe vascular device to a first diameter preferably comprises the step ofexposing the vascular device from a sheath of the delivery device toenable the vascular device to return a shape memorized configuration inresponse to being warmed by body temperature. The step of the deployingthe vascular device to an enlarged diameter in this embodimentpreferably includes the step of inflating a balloon positioned withinthe device.

Alternatively the step of deploying the vascular device to an enlargeddiameter comprises releasing the vascular device from the deliverydevice to enable it to return to a shape memorized condition andsubstantially simultaneously inflating a balloon.

The delivery device can be inserted through the jugular vein or femoralvein into the popliteal vein or the saphenous vein.

Replacement Valve

In another aspect, the present invention provides a replacement valvecomprising a support structure and a valve attached thereto, the valvebeing substantially conical in configuration and having a distal openingfacing away from the longitudinal axis when the valve is in the closedposition and aligned with the longitudinal axis when the valve is in theopen position.

In one embodiment the valve is attached to a proximal end of the supportstructure, and in another embodiment the valve is attached to a distalend of the support structure. In one embodiment, the valve is offsetwith respect to the longitudinal axis of the support structure. Thevalve can optionally include a plurality of drainage openings formed ina side wall adjacent the proximal end.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiment(s) of the present disclosure are described hereinwith reference to the drawings wherein:

FIG. 1 is a perspective view of a first embodiment of the vasculardevice of the present invention shown in the expanded configuration;

FIG. 2 is a side view of the vascular device of FIG. 1 in the expandedconfiguration;

FIG. 3 is another side view of the vascular device in the expandedconfiguration, rotated 45 degrees with respect to FIG. 2;

FIG. 4 is a front view of the vascular device of FIG. 1 in the expandedconfiguration;

FIG. 5 is a perspective view of the vascular device of FIG. 1 shown inthe collapsed configuration for delivery within the vessel;

FIG. 6 is a side view of the vascular device of FIG. 1 in the collapsedconfiguration;

FIG. 7 is another side view of the vascular device in the collapsedconfiguration, rotated 45 degrees with respect to FIG. 6;

FIG. 8 is a perspective view of an alternate embodiment of the vasculardevice of the present invention shown in the expanded configuration;

FIG. 9A is a side view of the vascular device of FIG. 8 shown in theexpanded configuration;

FIG. 9B is a side view similar to FIG. 9A except showing an alternateembodiment where the vessel engaging members extend at an angle into thevessel wall;

FIG. 10 is a perspective view of the vascular device of FIG. 8 in thecollapsed configuration for delivery within the vessel;

FIG. 11 is a side view of the vascular device of FIG. 8 in the collapsedconfiguration;

FIG. 12 illustrates one method of insertion of the vascular device ofFIG. 1 showing the delivery catheter inserted directly into thepopliteal vein in an antegrade direction;

FIG. 13 illustrates an alternate method of insertion of the vasculardevice of FIG. 1 through the jugular vein for retrograde insertion intothe popliteal vein;

FIG. 14 illustrates another method of insertion of the vascular deviceof FIG. 1 showing the delivery catheter inserted through the rightfemoral vein for retrograde access to the popliteal vein;

FIG. 15 illustrates yet another method of insertion of the vasculardevice of FIG. 1 showing a contralateral approach wherein the deliverycatheter is inserted through the left femoral vein for advancementaround the iliac vein for retrograde insertion into the right poplitealvein;

FIG. 16 shows a side view of the delivery catheter for the vasculardevice of FIG. 1, with the vessel wall shown in section, illustratingantegrade insertion of the delivery catheter in the popliteal vein;

FIG. 17 is a view similar to FIG. 16 showing initial withdrawal of thesheath in the direction of the arrow to partially expose the vasculardevice of FIG. 1;

FIG. 18 is a view similar to FIG. 16 showing the vascular device of FIG.1 expanded within the vessel, upstream (with respect to blood flow) ofthe valve leaflets, after the sheath has been fully withdrawn;

FIG. 19 is a view similar to FIG. 16, showing the vascular device ofFIG. 1 expanded by a balloon so the vessel engaging members penetrateand retain the vessel wall;

FIG. 20 is a view similar to FIG. 16, after the balloon is deflated andthe catheter withdrawn from the vessel, showing the vascular devicereturned to its original position pulling the vessel wall together andbringing the valve leaflets into apposition;

FIGS. 21A-21C are transverse cross-sectional views of the vasculardevice of FIG. 1 showing its interaction with the vessel wall duringdelivery and placement, wherein

-   -   FIG. 21A corresponds to the initial position of the vascular        device in FIG. 18 wherein the vessel engaging members have not        penetrated the vessel wall (the balloon has been omitted for        clarity);    -   FIG. 21B corresponds to the position of the vascular device in        FIG. 19 wherein the balloon has been inflated to radially expand        the device to a second expanded position to enable the vessel        engaging members to penetrate the vessel wall; and    -   FIG. 21C corresponds to the position of the vascular device in        FIG. 20 wherein the balloon has been deflated and the device        returns to the first expanded position bringing the vessel wall        radially inwardly;

FIG. 22 shows a side view of the delivery device for the vascular deviceof FIG. 1, with the vessel wall shown in section, illustrating as analternative, retrograde insertion of the delivery device in thepopliteal vein;

FIG. 23 is a view similar to FIG. 22 showing initial withdrawal of thesheath in the direction of the arrow to partially expose the vasculardevice of FIG. 1;

FIG. 24 is a view similar to FIG. 22 showing the vascular device of FIG.1 expanded within the vessel, upstream of the valve leaflets, after thesheath has been fully withdrawn;

FIG. 25 is a view similar to FIG. 22, showing the vascular device ofFIG. 1 expanded by a balloon so the vessel engaging members penetrateand retain the vessel wall;

FIG. 26 is a view similar to FIG. 22, after the balloon is deflated andthe catheter withdrawn from the vessel, showing the vascular devicereturned to its original position pulling the vessel wall together andbringing the valve leaflets into apposition;

FIG. 27 is a side view of an alternative embodiment of the vasculardevice in the expanded position shown within a vessel (the vessel wallis shown in section);

FIG. 28 is a view similar to FIG. 27 showing a balloon expanding thevascular device so the hooks penetrate the vessel wall;

FIG. 29 is an enlarged view of the hook of the device of FIG. 27embedded in the vessel wall;

FIG. 30 shows a side view of the delivery catheter for the vasculardevice of FIG. 1, with the vessel wall shown in section, illustrating asanother alternative, antegrade insertion of the delivery catheter in thepopliteal vein for positioning of the vascular device downstream of thevalve leaflets;

FIG. 31 is a view similar to FIG. 30 showing initial withdrawal of thesheath in the direction of the arrow to partially expose the vasculardevice of FIG. 1;

FIG. 32 is a side view of an alternate embodiment of the delivery systemof the present invention having a restraint, the view being similar toFIG. 23 in showing the vascular device expanded within the vessel,upstream of the valve leaflets, after the sheath has been withdrawn;

FIG. 33 is a view similar to FIG. 32, showing the vascular device ofFIG. 1 expanded by a balloon so the vessel engaging members penetrateand retain the vessel wall, and the restraint being severed by expansionof the balloon;

FIG. 34 is a transverse cross-sectional view of the vascular device ofFIG. 1 with the restraint of FIG. 32 shown expanded to the memorizedposition substantially simultaneously with expansion of the balloon;

FIG. 35A is a perspective view of the vascular device of the presentinvention having a first embodiment of a replacement valve attachedthereto, the device being shown in the expanded position and the valveshown in the open position;

FIG. 35B is a side view of the vascular device of FIG. 35A in thecollapsed position;

FIG. 36A is a side view of the vascular device of FIG. 35A shown in theexpanded position;

FIG. 36B is a side view of the vascular device similar to FIG. 36Aexcept showing the alternate embodiment of the vascular device havingangled vessel engaging members;

FIG. 37A is a transverse cross-sectional view of the vascular device ofFIG. 36A;

FIG. 37B is a transverse cross-sectional view of the vascular device ofFIG. 37A;

FIG. 38A is a perspective view of a second embodiment of the replacementvalve of the present invention shown in the closed position to preventblood flow therethrough, the vascular device being shown schematically;

FIG. 38B is perspective view of the valve of FIG. 38A in the openposition to enable blood flow;

FIG. 39A is a perspective view of a third embodiment of the replacementvalve of the present invention shown in the closed position to preventblood flow therethrough, the vascular device being shown schematically;

FIG. 39B is perspective view of the valve of FIG. 39A in the openposition to enable blood flow;

FIG. 40A is a perspective view of a fourth embodiment of the replacementvalve of the present invention shown in the closed position to preventblood flow therethrough, the vascular device being shown schematically;

FIG. 40B is perspective view showing the valve of FIG. 40A in the openposition to enable blood flow;

FIG. 41A is a perspective view of a fifth embodiment of the replacementvalve of the present invention having drainage slits formed therein andshown in the closed position to prevent blood flow therethrough, thevascular device being shown schematically;

FIG. 41B is perspective view showing the valve of FIG. 41A in the openposition to enable blood flow;

FIG. 42 is a perspective view of a sixth embodiment of the replacementvalve of the present invention, in the form of a duckbill valve, shownin the closed position to prevent blood flow therethrough, the vasculardevice being shown schematically;

FIG. 43 is perspective view of the valve of FIG. 42 in the open positionto enable blood flow;

FIG. 44 is a top view of the valve of FIG. 42;

FIG. 45 is a schematic view of two vascular devices with the offsetvalves of FIG. 41 inserted in the popliteal and femoral vein of apatient;

FIGS. 46A-46C illustrate sequentially the steps of insertion of thevascular device shown schematically with the offset valve of FIG. 41inserted into the popliteal vein wherein

-   -   FIG. 46A shows advancement of the delivery catheter and valve        through introducer sheath;    -   FIG. 46B shows withdrawal of the pusher from the delivery        catheter to release the vascular device;    -   FIG. 46C shows withdrawal of the delivery catheter for expansion        and placement of the vascular device;

FIGS. 47A-47C illustrate sequentially the steps of inserting a grasperto reposition the vascular device wherein

-   -   FIG. 47A illustrates the grasper and outer tube inserted through        the introducer sheath to access the vascular device;    -   FIG. 47B illustrates advancement of the prongs from the outer        tube towards the vascular device; and    -   FIG. 47C illustrates the vascular device grasped and moved        proximally by the prongs to a different location;

FIG. 48A is a cross-sectional view of a seventh embodiment of thereplacement valve of the present invention having a reinforcementtherein, and shown positioned with a covered stent;

FIG. 48B is a perspective view of the replacement valve of FIG. 48A,with a portion of the covered stent cut away, showing the valve in theclosed position;

FIG. 48C is a view similar to FIG. 48A except showing the valve in theopen position;

FIG. 49A is a top view of the vascular device and valve of FIG. 48;

FIG. 49B is a cross-sectional view taking along lines B-B of FIG. 49A;

FIG. 50 is perspective view of a first embodiment of a vascular devicein the form of an expandable cylinder and having an eighth embodiment ofthe replacement valve attached thereto, the valve shown in the closedposition;

FIG. 51 is a perspective view of the valve of FIG. 50 in the openposition to enable blood flow;

FIG. 52 is a perspective view of the vascular device of FIG. 50 having aninth embodiment of a replacement valve attached thereto, the valveshown in the open position;

FIG. 53 is a top view of the vascular device and valve of FIG. 52;

FIG. 54A is a bottom view of the vascular device of FIG. 52 shown in theexpanded position;

FIG. 54B is a bottom view of the vascular device in FIG. 52 shown in theretracted position; and

FIG. 55 is a cross-sectional view of a tenth embodiment of a replacementvalve in the form of an expandable cylinder having a duckbill valve.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring now in detail to the drawings where like reference numeralsidentify similar or like components throughout the several views, FIGS.1-7 illustrate a first embodiment of the vascular device of the presentinvention and FIGS. 8-11 illustrate a second embodiment of the vasculardevice of the present invention. The devices, designated generally byreference numerals 10 and 100, are expanded to engage the internal wallof the vessel and contracted to pull the vessel walls radially inwardly.By pulling the vessel wall radially inwardly, the valve leaflets withinthe vessel are pulled closer together to a functional condition.

FIGS. 1-4 illustrate vascular device 10 of the first embodiment in theexpanded configuration and FIGS. 5-7 illustrate vascular device 10 inthe collapsed configuration. Vascular device 10 is preferably composedof a shape memory material, such as a nickel-titanium alloy commonlyknown as Nitinol, so that in its memorized configuration it assumes theshape shown in FIG. 1. This shape memory material characteristicallyexhibits rigidity in the austenitic state and more flexibility in themartensitic state. To facilitate passage from the delivery catheter, theshape memory device is maintained in a collapsed configuration inside adelivery sheath as described in more detail below, where it is cooled bya saline solution to maintain the device below its transitiontemperature. The cold saline maintains the temperature dependent devicein a relatively softer condition as it is in the martensitic statewithin the sheath. This facilitates the exit of device 10 from thesheath as frictional contact between the device and the inner wall ofthe sheath would otherwise occur if the device was maintained in arigid, i.e. austenitic, condition. When the device 10 is released fromthe sheath to the target site, it is warmed by body temperature, therebytransitioning in response to this change in temperature to an austeniticexpanded condition.

Device 10 is preferably formed from a tubular member, preferably bylaser cutting. Device 10 includes a proximal portion 12, andintermediate portion 14 and a distal portion 16. In the expandedcondition, the device 10 has four substantially diamond shaped cells 17forming substantially diamond shaped openings 18 at the proximal portion12 and four substantially diamond shaped cells 15 forming substantiallydiamond shaped openings 20 at the distal portion 16. The end regions 19of the cells 18, and the end regions 21 of the cells 20 are bentoutwardly from the plane of the remainder of the cell, in a directionaway from the longitudinal axis of the vascular device 10. This betterenables the vessel engaging members, described below, to engage thevessel walls.

The intermediate portion 14 is formed of four substantially diamondshaped cells forming substantially diamond shaped openings 22 arrangedaround a 360 degree arc of the cylindrical tubular member 10, with alongitudinal strip 24 extending through to bisect each cell. Thus, foursymmetric bisected cells 23 are formed. Each longitudinal strip 24 has avessel engaging member 28 extending therefrom to engage the vessel wallas will be described below. In the expanded condition, the longitudinalstrip 24 buckles radially outwardly, away from the longitudinal axis ofthe vascular device 10, to enable the center vessel engaging members 28(described below) to engage and secure the internal vessel wall.

The geometry of the vascular device 10 can also be appreciated withreference to the collapsed configuration of the vascular device 10 shownin FIG. 5-7. As shown, the device 10 is in the form of a cylinder with areduced diameter. Each longitudinal strip 24 has a cutout 27 to formvessel engaging member 28. The longitudinal strip 24 is tapered in width“w” at its opposing ends 29 which connect to the framework. Thelongitudinal slot 30 on each side of the strip 24 is substantiallystraight and has enlarged oval-like regions 32 at opposing ends. Theouter wall 34 of each longitudinal slot 30, i.e. the wall of slot 34spaced further from the longitudinal strip 24, is joined to the outerwall 34 of an adjacent longitudinal slot 30 by transverse rib 36. Eachrib 36 forms one vertex of a cell 15 and one vertex of a cell 17 whenexpanded. The cell openings 18 and 20 in the collapsed configuration asshown in FIG. 6, have, respectively, a narrowed elongated portion 20 a,18 a, and a widened portion 20 b, 18 b with flared out regions 20 c, 18c, to form the diamond shaped openings having bent end regions 21, 19when device 10 is expanded. The flared out regions 20 c, 18 c enable theformation of such bent regions 21, 19.

A vessel engaging member extends from the framework of each of the cells15 and 17. The vessel engaging member is preferably in the form of ahook with a penetrating tip and a barb.

More specifically, a vessel engaging member 40 extends outwardly anddistally from the frame of each of the four cells 15 at the distalportion 16 of the device 10. In the collapsed configuration of device10, each member 40 preferably extends generally parallel to thelongitudinal axis of vascular device 10 and in substantially the sameplane as the corresponding rib 36 at the opposing end.

Similarly, vessel engaging members 42 extend outwardly and proximallyfrom the framework of each of the four cells 17 at the proximal portion12 of the device 10. In the collapsed configuration of device 10, eachmember 42 preferably extends generally parallel to the longitudinal axisof vascular device 10 and in the same plane as the corresponding rib 36at the opposing end

The four vessel engaging members 28 formed in the middle (intermediate)portion 14 in the collapsed configuration lie substantially parallel thelongitudinal axis of the device 10 and in the same plane as thelongitudinal strip 24 from which it is formed.

Each of the vessel engaging members 28, 40 and 42, are preferably in theform of a hook having a penetrating tip 29, 41 and 43 to pierce thevessel wall and a barb 31, 45 and 47, respectively, to help retain thevessel wall. The sharp penetrating tips 29, 41, 43 penetrate the vesselwall in a radial direction and hold the vessel against axial movementwith respect to the device 10; barbs 31, 45, 47, restrict radialmovement of the vessel with respect to the device 10, thereby togethersecurely retaining (grasping) the vessel wall for radial inward movementdescribed below.

It should be understood that although four vessel engaging members 42,40, 28 are described extending from the proximal and distal cells 17, 15and from the center longitudinal strips 24, respectively, a fewer orgreater number of vessel engaging members can be provided as long asthey achieve the vessel retaining function as described in more detailbelow.

When the vascular device 10 expands, members 28, 40 and 42 are moved toa shape memorized orientation bent outwardly at an angle, preferablyabout 90 degrees, with respect to the longitudinal axis “A” of thedevice 10 with regions 19 and 21 bending out of the plane to increasethe distance the members can extend from the center to the vessel wall.Longitudinal strips 24 buckle radially outwardly, and members 28 bendoutwardly at an angle, preferably about 90 degrees, with respect to thelongitudinal axis, to engage the vessel wall. Although 90 degree anglesare shown, clearly other angles are contemplated. Note that due to thegeometry of the device 10, the points at the outer edge come inwardlyaxially, shortening the length of the device, and the center strut(strip) 24 buckles radially outwardly. The buckling extends the radialreach of the device 10. Note also that in the expanded configuration,the tips of the vessel engaging members terminate at substantially thesame distance from the longitudinal axis of the device 10. The length ofthe end hooks is preferably the same as the length of the middle hooks;the bent regions 19, 21 accommodate for the buckling of strut 24. Due tothe laser cut configuration, foreshortening, i.e. the reduction inlength of the device in response to expansion, is reduced.

By way of example, for use for instance in an unhealthy dilated vesselof 14 mm. the length of the vascular device 10 in the collapsedconfiguration could be about 3 cm and the outer diameter about 3.5 mm.In the memorized expanded configuration, the length decreases to about2.8 cm and the transverse cross-sectional dimension increases to about12 mm, 15.5 mm if the 1.7 mm hooks are included. Note that the lengthchange is due mostly to the buckling strip and the bent regions sincethe amount of foreshortening is minimized. These dimensions are providedby way of example as other dimensions are clearly contemplated by thepresent invention and use in different size vessels is alsocontemplated.

An alternate preferred embodiment of the vascular device of the presentinvention is shown in FIGS. 8-11, with FIGS. 8 and 9 showing the devicein the expanded configuration and FIGS. 10-11 showing the collapsedconfiguration for delivery to the vessel.

Turning first to FIGS. 10 and 11, the device 100 is preferably laser cutfrom a cylindrical tube, forming a series, e.g. ten, of symmetricallongitudinal strips 102 terminating at opposite ends with vesselengaging members 110, 112. Each strip 102 has a longitudinal slot 104formed therein having a uniform width throughout its length. Adjacentstrips 102 are joined by transverse ribs or struts 106, creating a gap108, 109 on either side of the ribs 106 between strips 102.Consequently, the device can be considered as forming one centrallylocated column of slots 104 with ribs 106 in axial alignment and slots104 in axial alignment.

The vessel engaging members 110 and 112 are preferably in the form ofhooks as described above in the first embodiment with each vesselengaging member 110 having a penetrating tip 114 and barb 116 and eachmember 112 having a penetrating tip 118 and barb 119. The penetratingtips 114 and 118 penetrate the vessel wall and prevent axial movementwhile the barbs 116, 119 restrict radial movement. In the collapsedconfiguration, as shown, the vessel engaging members 110, 112 aresubstantially parallel to the longitudinal axis of device 100, lying inthe same plane as the respective longitudinal strip 102.

As shown, the cylindrical tubular member is formed into ten longitudinalstrips 102 with ten hooks 110 at the proximal end 105 and ten hooks 112at the distal end 107. Although ten longitudinal strips and ten vesselengaging members are shown on each end, it should be appreciated thatfewer or greater number of longitudinal strips and vessel engagingmembers can be utilized. Moreover, not all of the longitudinal stripsneed to terminate in vessel engaging members, provided a sufficientnumber of strips have vessel engaging members to adequately secure thevessel.

The structure of the vascular device 100 is shown in its first expandedconfiguration in FIGS. 8 and 9. Vascular device 100, like device 10, iscomposed of a shape memory material, such as Nitinol, so that in itsmemorized configuration it assumes the shape shown in FIG. 8. The shapememory device is maintained in a collapsed configuration inside a sheathas described in more detail below, where it is cooled by a salinesolution to maintain the device below its transition temperature. Whenthe device 100 is delivered to the target site and released from thesheath, it is warmed by body temperature, thereby transitioning inresponse to this change in temperature to an austenitic expandedcondition. Maintenance of the device in its softened martensitic statewithin the sheath facilitates delivery to the vessel as frictionalcontact between the device 100 and the internal walls of the deliverysheath would otherwise occur if the device was retained within thesheath in its austenitic condition.

When expanded, longitudinal slots 104 form substantially diamond shapedcells 120 with substantially diamond shaped openings 122. Uponexpansion, the vessel engaging members 110 and 112 extend at an angle,preferably about 90 degrees, to the longitudinal axis of the vasculardevice 10 to enable the vessel engaging members 110 and 112 to engageand secure the vessel wall (see e.g. FIG. 9A). However, it is alsocontemplated that the vessel engaging members 110′,112′ could extend ata different angle, for example about 60 degrees, as shown in thealternative embodiment of FIG. 9B.

As the device moves from the collapsed configuration to the expandedconfiguration, it shortens in axial length as the diameter increases.For example, in one embodiment the length of the vascular device 100 inthe collapsed configuration is about 1.8 cm and the diameter is about3.5 mm. In the expanded configuration, the length decreases to about 1cm, mainly due to the hooks bending up as foreshortening is minimized,and the diameter in the memorized expanded configuration increases toabout 12 mm. (15.5. if the 1.75 mm hook length is included). Thesedimensions are provided by way of example as other dimensions areclearly contemplated.

Turning to the method of use of the vascular devices of the presentinvention, the insertion of vascular device 10 will be described, itbeing understood that vascular device 100 would be inserted in the samemanner and expanded and retracted in the same manner as device 10.

There are several different methods of insertion of the vascular deviceof the present invention for treating venous valve insufficiency of thepopliteal or saphenous vein. FIGS. 12-15 illustrate examples of some ofthese approaches by illustrating various access vessels for the deliverydevices to reach these veins. In FIG. 12, the catheter 200 is placedinto the popliteal vein “P” in the patient's leg “G” and advanced to aregion adjacent the leaflets “T” to deploy the vascular device upstreamof the leaflets. The delivery catheter is thus delivered in an antegradefashion, with the tip extending downstream of leaflets “T” to deploy thedevice just upstream (defined in reference to the direction of bloodflow) of the leaflets.

In the approach of FIG. 13, the catheter 210 is inserted through theright jugular vein “J”, where it will be advanced through the superiorand inferior vena cava, past the iliac vein “I”, through the femoralvein “F” and into the popliteal vein “P” through leaflets “L” in aretrograde fashion, i.e. opposite the direction of blood flow. Thedelivery catheter 210 would thus extend through the leaflet region justupstream of the leaflets. In FIG. 14, the catheter 220 is placed in theright femoral vein “F”, where it will be advanced in a retrograde mannerto the popliteal vein “P” in the manner described above with respect toFIG. 13.

In the contralateral approach of FIG. 15, the catheter 230 is insertedthrough the left femoral vein “H” where it will be advanced around theiliac vein “I” and through the left femoral vein “F” into the poplitealvein “P.”

Each of the delivery catheters 200, 210, 220 and 230 has respectivetubing 202, 212, 222 and 232, with a stopcock 204, 214, 224 and 234 tocontrol saline infusion through the catheter to maintain the vasculardevice 10 (or device 100) in the cooled martensitic collapsedconfiguration for delivery. Inflation port 206, 216, 226 and 236provides for fluid infusion to inflate the balloon which is mounted onthe catheter shaft and positioned within the device 10. The outer sheathof the delivery catheter slides with respect to the catheter shaft toexpose the vascular device. Guidewire port 208, 218, 228 and 238 enablesinsertion of a conventional guidewire (not shown) to guide the deliverycatheter intravascularly to the target site. A conventional access orintroducer sheath (not shown) would be inserted through the skin andinto the access vessel, and the respective delivery catheter would beinserted into the access vessel through the introducer sheath.

FIGS. 16-20 illustrate the method steps of insertion of the vasculardevice 10 in an antegrade fashion intravascularly in the popliteal vein“P”. Catheter or delivery sheath 200 is inserted over a conventionalguidewire (not shown) so the distal tip 201 of the catheter shaftextends past, i.e. downstream of the valve leaflets L extendingannularly from vessel wall “V” as shown in FIG. 16. As can beappreciated, since there is a gap “a” between the valve leaflets “L”,the valve cannot function properly because the leaflets cannot properlyclose to prevent backflow. Also, due to the malfunctioning of the valve,the vessel wall becomes dilated as shown as the weight and pressure ofthe backflow blood pushes out the vessel wall.

Once the position of the sheath 200 is confirmed by venography,intravascular ultrasound, or other means, the sheath 205 is withdrawnwith respect to catheter tip 201 in the direction of the arrow of FIG.17, exposing the vascular device 10. When the sheath 205 has been fullywithdrawn to expose the device 10, the device is warmed by the bodytemperature and transitions to its austenitic phase and the firstmemorized expanded configuration of FIG. 18.

Next, a balloon member 240 on catheter shaft 209 which is positionedwithin device 10 is inflated via introduction of fluid through inflationlumen 206 (FIG. 12) to further expand the device 10 to a second expandedconfiguration shown in FIG. 19. That is, the device is expanded to alarger diameter than the diameter in its memorized configuration of FIG.18 so that vessel engaging members 28, 40 and 42 will engage the vesselwall “V” with the sharp tips and barbs penetrating the vessel wall tofirmly grasp and secure it. This securement restricts both radial andaxial movement of the vessel to enhance retention by the device 10.

After retention of the vessel wall as in FIG. 19, the balloon isdeflated (and the catheter 200 removed), resulting in the device 10contracting from the second expanded configuration towards its memorizedconfiguration. Preferably, the device 10 will return to substantiallythe same diameter as the first (memorized) expanded configuration. Ascontracted, the device 10, due to the engagement of the vessel engagingmembers with the internal wall of the vessel, pulls the vessel wallradially inwardly, thereby pulling the leaflets radially inwardly to theposition of FIG. 20 to close gap “a”. As can be appreciated, the vesselwall is no longer dilated and the valve leaflets are sufficientlyapproximated such that their tips contact to block backflow and theirfunction is therefore restored. The device 10 remains inside the vessel,maintaining the approximation of the vessel wall to maintain the properfunctioning of the leaflets.

The changing diameters of the vascular device 10 can also be appreciatedby reference to the transverse cross-sectional views of FIG. 21A-21C.The delivery device has been removed for clarity. More specifically,FIG. 21A corresponds to the initial position of the vascular device 10in FIG. 18 wherein the device 10 has been delivered to the targetvessel, and has expanded to the first expanded (memorized) configurationbut the vessel engaging members have not penetrated the vessel wall. Itshould be appreciated that in this configuration the vessel engagingmembers may or may not be in contact with the vessel wall, but in eithercase, do not fully penetrate and secure the vessel to the same extent asin the second position. As shown, by way of example, the unhealthydilated vessel can have an internal diameter D1 of approximately 14 mm.The balloon is not shown in FIG. 21A for clarity.

FIG. 21B corresponds to the position of the vascular device in FIG. 19wherein the balloon has been inflated to radially expand the device 10to a second expanded position to enable the vessel engaging members topenetrate and retain (secure) the vessel wall. In this configuration,the vessel wall is further expanded to a diameter D2 of about 16 mm, asthe device is expanded to a diameter of about 16 mm, with the hooksextending an additional 2 mm so the device is expanded to 20 mm.

FIG. 21C corresponds to the position of the vascular device 10 in FIG.20 wherein the balloon has been deflated and the device contracted tobring the vessel wall radially inwardly. The internal vessel walldiameter will preferably be about 12mm to close the gap between theleaflets. The diameter of the vascular device 10 preferably returns tothe same diameter as in FIG. 21A, e.g. about 12 mm. As can be seen thedevice 10 abuts the vessel wall V.

FIGS. 22-26 illustrate retrograde insertion of the vascular device 10.In this approach the delivery catheter, e.g. catheter 210, is insertedin a direction against the blood flow so tip 211 extends past the valveleaflets “L” in the popliteal vein “P” and the catheter 210 ispositioned so the device 10 will be deployed upstream of the leaflets.The deployment of the device 10 is otherwise the same as in FIGS. 16-20.That is, sheath 215 of the delivery device 210 is retracted in thedirection of the arrow of FIG. 23, to expose the device 10. Fullretraction and removal of the sheath 215 to expose the device to thewarmer body temperature enables it to expand to its memorized (firstexpanded) configuration of FIG. 24. Subsequent expansion of balloon 250(FIG. 25) causes the vessel engaging members 42, 28, 40 to penetrate andretain the vessel wall so that upon deflation of the balloon, the device10 returns to the memorized configuration of FIG. 26 pulling the vesselwall inwardly and bringing the valve leaflets “L” closer together intoapposition so the tips can contact. The changing diameters would alsocorrespond to the aforedescribed transverse cross-sections of FIG.21A-21C.

As can be appreciated, device 10 and device 100 are each symmetrical sothat the “proximal” and “distal” portions are identified herein forconvenience.

FIGS. 27-29 illustrate an alternate embodiment of the vascular devicedesignated generally by reference numeral 300. This shape memory device300 is illustrated and described in Provisional patent application No.60/214,120, filed Jun. 6, 2000, the entire contents of which areincorporated herein by reference. Device 300 is placed within vessel V,e.g. the popliteal vein, to approximate leaflets “L” which as shown inFIG. 27 are not functioning properly because the tips L1 are spacedapart. In its first expanded configuration corresponding to itsmemorized shape of FIG. 27, hooks 314 have not penetrated the vesselwall. The device 300 is formed by struts 302 as described in detail inthe '120 application. Hooks 314, affixed to struts 302 at region 304 arecrescent shaped and have pointed ends 306 with barbed portions 308.

In the expanded configuration of FIG. 28, balloon 322 on shaft 324 ofthe delivery device has expanded the device 300 so that hooks 314penetrate and securely engage the vessel wall “V”. The balloon wouldthen be deflated and the device 300 would return to its first expandedconfiguration bringing the vessel walls radially inwardly and bringingthe valve leaflets into apposition in the same manner as described abovewith respect to vascular device 10.

FIGS. 30 and 31 illustrate an alternate method of placement of thevascular device. In this method, the vascular device 10 (or vasculardevice 100) is placed downstream (with respect to the direction of bloodflow) of the valve leaflets. The delivery catheter 210′ is inserted inthe same antegrade manner as described above with respect to FIG. 16,except it is advanced sufficiently past the valve leaflets L to enabledownstream delivery of the device 10. Once positioned as shown in FIG.31, the sheath 215′ is withdrawn in the direction of the arrow, enablingthe device 10 to expand to its memorized configuration. Vascular device10 would then be further expanded by a balloon and then enabled tocontract to its memorized configuration in the same manner as in FIGS.18-20, the only difference being that the device 10 would grasp thevessel wall downstream of the valve leaflets to pull the vessel wallradially inwardly to bring the leaflets into apposition.

It should be appreciated that the device 10 or device 100 could also bedelivered in a retrograde fashion such as shown in FIGS. 13-15 forpositioning of the device downstream of the leaflets L.

FIGS. 32-34 illustrate an alternative delivery system and method forvascular device 10 (or device 100 which can be delivered in the samemanner). In this method, exposure of the vascular device to bodytemperature and expansion of the balloon occur substantiallysimultaneously. To facilitate placement, a restraint system forconnecting the vascular device to the balloon is provided.

More specifically, balloon 250′ has a pair of sutures 252 attachedthereto at a proximal and distal portion which wrap around the vasculardevice 10 forming a loop of suture to connect the balloon and thedevice. Although two sutures, are shown, it is contemplated that onesuture or more than two sutures can be utilized to connect the balloon250′ to the vascular device 10. Additionally, other restraint systemssuch as perforated strips can be utilized.

In the position of FIG. 32, the sutures (only one of which is shown, theother suture still within the sheath 215′) are loosely wrapped aroundthe device. As the sheath 215′ is retracted in the direction of thearrow, the balloon is inflated. Thus, as the sheath 215′ is fullywithdrawn, the device expands to the position of FIG. 33, without theintermediate step required in the methods described above, i.e. withoutthe step of FIG. 24 which first allows the device to expand to thememorized configuration. As the balloon expands, the pressure againstthe sutures 252 breaks the suture loops, thereby releasing them from thevascular device 10. This way, when the balloon 250′ is deflated andwithdrawn with the delivery catheter 210′ from the body, the sutures 252are removed as well. Upon deflation, the vascular device 10 returns toits memorized configuration to pull the vessel wall radially inwardly inthe manner described above to assume a position like that of FIG. 26.

Note that it is also contemplated that the balloon 250′ can be inflatedfirst within the sheath, followed by withdrawal of the sheath to exposethe vascular device 10 to body temperature.

Additionally, the restraint system can also be utilized with thesequential method of deployment of FIGS. 16-20 and FIGS. 22-26. Therestraint system, e.g. the sutures, would help prevent axial movementand help center the balloon with respect to the vascular device 10.Other restraint systems, such as a strap, could be used to releasablyconnect the vascular device to the balloon.

As an alternative to shape memory, a stainless steel or polymericvascular device. Such device would be expanded by a balloon below itselastic limit, thus enabling the device to return to its smallerconfiguration after the balloon is deflated. The vascular device couldalso be in the form of a braided structure which can be expanded toengage the vessel wall by squeezing or compressing its end(s), and thenreleasing it to enable it to return to its more elongated position ofreduced diameter to approximate the vessel wall.

Vascular Device with Replacement Valve

The foregoing embodiments of FIGS. 1-34 describe and show vasculardevices which bring the vessel wall radially inwardly to approximate thepatient's existing valve leaflets of the patient. In another aspect ofthe present invention, instead of approximating the valve leaflets, thevascular device inserted in the vessel has a replacement valve attachedthereto. Thus, the vascular device is inserted to expand and contract asdescribed above, bringing the dilated vessel wall radially inwardly andleaving the replacement valve inside the vessel attached to theimplanted vascular device. This replacement valve can be utilized as atotal replacement wherein the patient's valve leaflets are removed, orcan be placed upstream or downstream of the patient's leaflets, leavingthe nonfunctioning leaflets in place. Various embodiments of valveconfigurations used in conjunction with vascular devices are describedin detail below and illustrated in FIGS. 38-48. FIGS. 38-48, forsimplicity, show the vascular device schematically, it being understoodthat any of the foregoing vascular devices can be utilized with thevarious valve configurations. The valves can be attached at the proximalend, distal end, or intermediate the proximal and distal ends of thevascular devices.

Turning first to FIGS. 35A-37, vascular device 400 is substantiallyidentical to vascular device 100 of FIG. 9A, except for the provision ofvalve 450. For this reason, it has been labeled with a differentreference numeral. Valve 450 is conically shaped and is secured tovascular device 400 by various techniques such as by being molded ontothe frame or sewn onto the frame. A pair of elongated supports 455extends from the device into the valve 450 which spread to close thevalve and move inwardly to open the valve. The valve 450 is shownattached to the distal end to extend downstream of the device 400, withrespect to blood flow. The valve 450 is shown in the open position inthe figures and would collapse to a closed position by spreading of thesupports 455, operating like a duckbill valve.

As an alternative, the supports 455 are not provided and the valve 450functions in a similar manner described below with respect to the otherconical valves, e.g. valve 500.

A reinforcement ring as described below could also optionally beprovided. Valve 450 can be multi-layered, with an outer layer 452composed of one material and an inner layer 454 composed of anothermaterial as shown in FIG. 37A. Possible valve materials are discussedbelow

It should be appreciated that the vessel engaging members 451 can extendsubstantially perpendicular as shown in FIG. 36A, or can extend at anangle as described above with respect to FIG. 9B. (See vessel engagingmembers 451′ of FIG. 36B). Also, although the vessel engaging members ofFIG. 35A are slightly longer and are bent at a different region than thedevice of FIG. 9A, it should be understood that the device of FIG. 9Acan be provided with valve 450 or any of the other valve configurationsdescribed herein.

Turning now to FIGS. 38-47, the vascular device, since it is shownschematically for ease of reference, will be referred to in each of thedrawings by reference letter “D”, it being understood that preferablyvascular device 100 is utilized, although device 10 and other supportstructures could alternatively be used.

With reference first to FIGS. 38A and 38B, valve 500 is conical in shapeand has an open proximal end 504 and an open distal end 502. Thisconical shape results in backflow of blood causing the valve to close.When the valve 500 is in the position of FIG. 38A, distal opening facestowards and can press against the vessel wall to prevent flow throughthe valve 500. The force of the blood during systole straightens thedistal end 502 to the position of FIG. 38B to allow blood flowtherethrough. Reinforcement ring 506 helps to maintain the valve 500 inthe open position. As shown, valve 500 extends distally of the device Dso it is positioned downstream with respect to blood flow of the device.

FIGS. 39A and 39B illustrate a variation to the valve configuration ofFIG. 38 in that it is similar to valve 500 except that the valve 520 isattached to a proximal end E of the vascular device D. Valve 520 isattached at points E1, E2, etc. around the circumference and extendsupwardly through a central portion of the device “D”. Reinforcement ring526 functions to help maintain the valve 520 in the open position ofFIG. 39B. FIG. 39A shows the valve 520 in the closed position and FIG.39B illustrates the valve in the open position to enable blood flowtherethrough. In both positions, the valve extends within vasculardevice D.

In the embodiment of FIG. 40, the valve 550 is attached to the distalend of vascular device D and has a plurality of leaflets or petals 552arranged circumferentially thereabout. The leaflets fold inwardlytowards each other in the closed position of FIG. 40A to prevent bloodflow. The pressure of the blood during systole forces the leaflets apartto the open position as shown in FIG. 40B.

In the embodiment of FIGS. 41A and 41B, valve 560 is conically shapedlike the valves of FIGS. 38 and 39, but is offset from the centrallongitudinal axis of vascular device D. Additionally, eccentric valve560 differs from valves 500 and 520 in that it has a plurality of slits562 at a proximal portion to enable drainage of blood to reduce bloodbuildup. That is during the diastole phase, the slits expand to largerholes as shown in FIG. 41A and the blood draws through the holes.Reinforcement ring 566 functions as described above to help retain thedistal end open.

A duckbill valve 570 is illustrated in the embodiment of FIGS. 42-44.Valve 570 is attached at the distal end of vascular device D and ismoved to the open position as shown in FIG. 43 by blood flow to enablepassage therethrough. The closed position of the valve is illustrated inFIGS. 42 and 44. The proximal region of valve 570 is slightly tapered.As with any of the foregoing valves, valve 570 can be attached at theproximal end, distal end, or intermediate portion of the vasculardevice.

FIGS. 45-47 illustrate steps for placement of the vascular device of thepresent invention. FIG. 45 shows placement in the popliteal vein “P” andthe femoral vein “F” of the vascular device of FIG. 41 by way ofexample, it being understood that any of the vascular devices with anyof the valve configurations can be placed in a similar fashion.Placement of two vascular devices is shown, although only one vasculardevice D (shown schematically) or more than two can be utilized. In FIG.46A, the vascular device and valve 560 are introduced through introducersheath 600 in a collapsed position. The device is retained within adelivery catheter 604. After introduction of the catheter 604 throughthe introducer sheath 600 to the surgical site, the pusher 606 pushesthe device to the end of the catheter 604, is then retracted, followedby retraction of the catheter 604, thereby releasing the device andallowing it to expand to the memorized configuration as shown in FIG.46C for retention in the vein. Alternatively, the pusher can be used tofully advance the device from the catheter 604.

If it is desired to reposition the device, grasper 610 within deliverycatheter 604 is inserted through the introducer sheath 602. The prongsor fingers 612 are advanced from the outer tube 614 of grasper 610, orthe outer tube 614 is moved proximally, to expose the prongs 612. Theouter tube 614 is then advanced slightly to slightly clinch the prongs612 so the prongs 612 can grasp the vascular device D and pull it to amore proximal position as shown in FIG. 47C. The grasper 610 is thenremoved. Note valve 560 is shown in the open position in FIGS. 47A-47C.

In the embodiment of FIGS. 48-49, valve 700 is in the form of a duckbillvalve similar to FIGS. 42-44, except the valve is reinforced with metalwires or struts 701. The vascular device is shown in the form of acovered stent 702, with the metal stent 703 embedded in the graftmaterial 704. The valve can include blood drainage slits 706 as shown.

Replacement Valve

The present invention also contemplates in another aspect use of thevarious valve configurations as replacement valves without the use of avascular device which brings the walls radially inwardly. The patient'svalve can be removed or alternatively left in place and the replacementvalve of the present invention placed upstream or downstream of thepatient's valve. In such applications, the valve is attached to asupport structure, such as a shape memory stent, and is maintained in anopen position within the vessel to retain the valve. FIGS. 50 and 51shown an example of a type of support structure for holding the valve.

More specifically, in the embodiment of FIGS. 50 and 51, instead of ametal framework, the valve 750 is attached to a rolled up cylindricalring or metal band 752. The ring 752 can be made of shape memorymaterial with its memorized position being an expanded position of FIGS.50 and 51. The valve 750 is similar to valve 500 of FIG. 38A, except ithas a larger reinforcement ring 754, and is cylindrical instead ofconical in configuration.

In the embodiment of FIGS. 52-54, the valve 800 has a plurality ofdrainage holes 802 which function in a similar manner as drainage slits562 of valve 560 of FIGS. 38-39. The overlapping cylindrical supportmember 806 is shown in the contracted delivery position in FIG. 54B andin the expanded position in FIG. 54A. Valve 800 is longitudinally offsetwith respect to cylindrical member 806.

In the embodiment of FIG. 55, valve 850 is in the form of a duckbillvalve and extends from cylindrical support member 856.

It should be appreciated that the valves 850, 800 and 750 can be usedwith any of the vascular devices described above. Conversely, any of theforegoing valves can be used with cylindrical supports 752, 806. Also,the valves can be attached at the proximal end, distal end, orintermediate the proximal and distal ends of the vascular devices.

The foregoing valves can be attached to the vascular devices, theframework structures and the cylinders, by sewing, molding or othertechniques. The valves can be composed of a variety of materials such asPET, PTFE, polycarbonate polyurethane, swine intestinal submucosa,collagen and other biomaterials. The valve and /or the vascular devicesurface can optionally be coated with anti-platelet oranti-thrombin/anti-clotting materials, 2b/2a coating, receptors, heparincoating, endothelial cell coating, etc.

While the above description contains many specifics, those specificsshould not be construed, as limitations on the scope of the disclosure,but merely as exemplifications of preferred embodiments thereof. Forexample, instead of a balloon to expand the device to its secondexpanded diameter/condition, a mechanical means such as an expandablewire frame can be utilized. Also, instead of moving the sheath to exposethe vascular device, the catheter can be advanced with respect to thesheath or both the catheter and sheath can move relative to each otherin opposite directions. Those skilled in the art will envision manyother possible variations that are within the scope and spirit of thedisclosure as defined by the claims appended hereto.

What is claimed is:
 1. A vascular device for treating venous valveinsufficiency by an intravascular approach to a target vessel, thedevice comprising a body and a plurality of vessel penetrating membersextending radially from the body in a direction away from a longitudinalaxis of the body, the body composed of shape memory material with a lowprofile insertion position of a first cross-sectional dimension, a shapememorized configuration being of a second reduced cross-sectionaldimension but of larger cross-sectional dimension than the first crosssectional dimension and a vessel wall engagement position having a thirdcross-sectional dimension greater than the second cross-sectionaldimension, the vessel engaging members having penetrating tips topenetrate the vessel wall and securely grasp the vessel wall forapproximation of the wall, the body movable from the vessel wallengagement position, wherein the penetrating tips of the vessel engagingmembers penetrate to grasp the vessel wall, toward the shape memorizedconfiguration to thereby bring the vessel wall radially inwardly so thevessel wall is changed from a first diameter to a second diameter, thesecond diameter being less than the first diameter, such reduction indiameter enabling the treatment of venous valve insufficiency by one ofa) bringing the vessel wall to the second diameter such that existingvalve leaflets extending radially inwardly from an internal portion ofthe vessel wall move closer together to thereby reduce a gap in theleaflets to prevent retrograde flow which gap otherwise is insufficientfor proper closing of the valve which results in improper functioning ofthe valves such that retrograde blood flow is not prevented or b)implantation of a replacement valve extending from the vascular deviceand connected thereto and implanted with the vascular device to preventretrograde blood flow as the replacement valve moves to a closedposition.
 2. The device of claim 1, wherein the device is expandable bya balloon positionable within an internal portion of the body.
 3. Thedevice of claim 1, wherein the penetrating tips include a hook having apiercing tip to prevent axial movement of the pierced vessel and a barbto restrict radial movement of the pierced vessel.
 4. The device ofclaim 1, wherein the device is laser cut from a tube.
 5. The device ofclaim 1, wherein the vascular device is positionable upstream of theleaflets of the vessel.
 6. The device of claim 5, wherein exposure ofthe vascular device from the delivery member enables the body to expandfrom a collapsed insertion position.
 7. The device of claim 1, whereinthe vascular device is positionable downstream of the leaflets of thevessel.
 8. The device of claim 7, wherein exposure of the vasculardevice from a delivery member enables the body to expand from acollapsed insertion position.
 9. The device of claim 1, wherein thedevice includes a replacement valve having a closed position to preventblood flow and an open position to enable blood flow therethrough, and aplurality of supports extending into the replacement valve which aremovable to move the replacement valve between the closed and openedpositions.
 10. The device of claim 9, wherein the device is expandableby a balloon positionable within an internal portion of the body. 11.The device of claim 9, wherein the penetrating tips include a hookhaving a piercing tip to prevent axial movement of the pierced vesseland a barb to restrict radial movement of the pierced vessel.